The National Institute for Clinical Excellence is examining partial left ventriculectomy and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about partial left ventriculectomy.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 25 November 2003

Target date for publication of guidance: May 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of partial left ventriculectomy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake partial left ventriculectomy should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

This is a radical treatment for very ill patients that should only be undertaken in centres where alternative treatments for severe heart failure are available.

Partial left ventriculectomy is used to treat patients with irreversible (end-stage) heart failure secondary to dilated or hypertrophic cardiomyopathy, valvular disease, or Chagas' disease. It has also been used in some patients with ischaemic heart disease.

Surgical alternatives to partial left ventriculectomy include coronary artery bypass grafting (CABG), cardiac transplant, intra-aortic balloon pumping and left ventricular assist devices (LVAD). Ventricular volume reduction procedures include mitral valve repair (mitral annuloplasty), endoventricular circular patch plasty and left ventricular aneurysmectomy. Medical therapy includes vasodilator therapy, digitalis, and dobutamine infusion.

Partial left ventriculectomy (PLV) seeks to restore left ventricular function by reducing cardiac volume (and left ventricular wall tension) through the resection of the posterolateral wall of the left ventricle. It is often accompanied by valvuplasty (or mitral annuloplasty) to prevent postoperative mitral regurgitation. Variations of the technique for PLV include lateral PLV, extended PLV and anterior PLV. The procedure is performed either on a beating heart or during cardiopulmonary bypass

In lateral PLV an incision is made at the apex of the left ventricle and extended towards the base. A wedge-shaped portion of the left ventricle is resected, leaving the papillary muscles intact where possible. Extended PLV additionally excises the papillary muscles and the mitral valve. In anterior PLV, the area between the left anterior descending artery and the attachment of the left anterolateral papillary muscle is resected and closed as in lateral PLV.

Studies reported 30-day survival rates of between 50% and 99%. In one non-randomised study, there was no difference in survival rates between patients undergoing this procedure and patients undergoing heart transplant at 1 year. In a case series of 62 patients, survival was 80% and 60% and event-free survival was 49% and 26%, at 1 and 3 years after surgery respectively. The survival rate at 1 year was achieved with the excessive use of ventricular assist devices and transplantation as salvage therapy. For more information, refer to the Overview (see Appendix).

All the Specialist Advisors thought that efficacy, especially long-term efficacy was uncertain. One Advisor commented that it is difficult to establish which patients would benefit from the procedure and that there is often no improvement in myocardial function. Another Advisor considered it most effective in patients with end-stage left ventricular failure, but added that complications were numerous and recommended that the procedure should only be performed in specialist centres.

As noted in Section 2.3.1, 30-day mortality ranged from 1% to 50%. However, it is unclear from the studies whether these deaths were the result of the procedure or attributable to the underlying condition. Reported complications included congestive heart failure, bleeding, arrhythmias, renal failure, respiratory failure and infection. For more information, refer to the Overview (see Appendix).

The Specialist Advisors were concerned about the high (30-day) mortality rate associated with this procedure. One Advisor listed late complications as arrhythmias, mitral regurgitation, and progressive dilation of the left ventricular. The same Advisor considered the main disadvantage of the procedure was the need for resection of viable myocardium.

The evidence for this procedure is difficult to interpret because of:

• inconsistencies in patient selection
• the variable nature of the surgery performed
• inadequate information about duration and quality of life after the operation.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making it's provisional recommendations.

• Interventional Procedure Overview of Partial left ventriculectomy, October 2002

Available from: www.nice.org.uk/ip060overview